Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Participants will be randomised to consume a high dairy diet (>4 serves/day, low fat dairy <2% fat) for 12 months. A serve of dairy is based on Australian standardised serves, for example 1 serve of milk is 250mL or 1 cup. Foods will be provided for the volunteers for the duration of the trial. Compliance will be measured using weekly dairy consumption logs and weighed food records (at 0, 3, 6 and 12 months).

Query!

Intervention code [1]33530

Prevention

Query!

Comparator / control treatment

Low dairy diet (<1serve/day). A serve of dairy is based on Australian standardised serves, for example 1 serve of milk is 250mL or 1 cup. Compliance will be measured using weighed food records at 0, 3, 6 and 12 months.

Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Subjects meeting entry criteria at screening will be allocated to a treatment at random by the study code-holder who will remain blinded to their identities. The code-holder will be contacted by electronic mail and provided with the age, gender and BMI of the individual to be randomised.

Query!

Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

Stratified allocation of de-identified subjects based on age, gender and BMI. Stratified allocation of de-identified subjects based on age, gender and BMI will be done using permuted block randomisation.